Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

NCT ID: NCT07047859

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2029-05-31

Brief Summary

This prospective, single-center observational study evaluates the clinical utility of intraoperative sympathetic nerve width measurement during thoracoscopic sympathectomy (ETS) for palmar/craniofacial hyperhidrosis (PH/CH) and facial blushing (FF). The study aims to correlate nerve width-measured using a novel Rapid Intraoperative Sympathetic Nerve Width System (RMSNW-OS) (±0.2mm precision)-with surgical outcomes, compensatory sweating rates, patient satisfaction, and 12-month efficacy.

Approximately 1,000 patients (aged 18-55) will undergo standardized ETS at Shanghai First People's Hospital (2025-2029). Objective metrics include thermographic (palmar/forehead temperature), hemodynamic (HR/BP), biochemical (catecholamines), and Doppler flow measurements. Patient-reported outcomes use diagnosis-specific binary questionnaires and the Hyperhidrosis Disease Severity Scale (HDSS).

Statistical analysis will determine if nerve width predicts treatment response. Innovations include RMSNW-OS standardization and a multidimensional assessment framework to optimize ETS precision and patient quality of life.

Conditions

Thoracoscopic Sympathectomy (ETS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing).

2. Age : ≥18 years and ≤55 years.

3. Cardiopulmonary Function :

Normal preoperative chest CT scan and electrocardiogram (ECG).

4. Performance Status : ECOG score (see Attachment 1) of 0-1, indicating good clinical fitness and ability to perform daily activities independently.

5. Informed Consent : Patients and their families fully understand the study's purpose, procedures, risks, and potential benefits, voluntarily sign the Informed Consent Form, and agree to participate.

Exclusion Criteria

1. Abnormal Preoperative ECG :

1. Severe arrhythmias:

1. Type II second-degree or higher atrioventricular block.

2. Symptomatic ventricular arrhythmias.

3. Uncontrolled supraventricular arrhythmias (resting heart rate >100 bpm). These may cause inadequate cardiac output, hypoperfusion of vital organs, and increased surgical risk.

2. Myocardial ischemia or infarction:

1. ECG showing ST-segment elevation/depression, T-wave inversion.

2. Pathological Q-waves indicating myocardial infarction. 2. Abnormal Chest CT :

1) Severe pulmonary infections (e.g., lobar pneumonia, empyema) with symptoms like fever, cough, dyspnea. Surgery increases infection risk and may lead to atelectasis or respiratory failure.

2) Pneumothorax or tension pneumothorax:

1. Significant lung collapse causing dyspnea.

2. Tension pneumothorax requiring immediate chest tube drainage. 3) Pleural effusion (moderate/large volume): Causes dyspnea or mediastinal shift; surgery may worsen respiratory function.

3. Hyperthyroidism-induced facial blushing or generalized hyperhidrosis. 4. Anesthesia Contraindications : Allergy to anesthetics or high-risk conditions (severe pulmonary/cardiac dysfunction).

5. Cognitive/Psychiatric Impairment : Inability to provide informed consent or understand study risks.

6. Non-Compliance with Follow-up : Inability to adhere to postoperative visits.

7. Immunodeficiency Disorders : Severe immunodeficiency, AIDS, or organ transplant history.

8. Frailty/Advanced Age : Elderly patients with comorbidities or functional decline unfit for surgery.

9. Severe Organ Dysfunction : Cirrhosis, renal failure, or inability to tolerate surgery/recovery.

10. Active Infections : Under antibiotic treatment for pneumonia, tuberculosis, or bacterial infections.

11. Uncontrolled Diabetes : Poor glycemic control with complications (retinopathy, diabetic foot).

12. Concurrent Clinical Trials : Participation in other interventional studies affecting results.

13. Severe Malnutrition : Significant weight loss or nutritional deficiency increasing anesthesia/surgical risks.

14. Hematologic Disorders : Anemia, thrombocytopenia, or coagulopathies affecting hemostasis/recovery.

15. Severe Chronic Respiratory Failure : Long-term ventilator dependence or tracheostomy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Jiang Fan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Hongkou Distri 200080

Locations

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Countries

China

Central Contacts

Qiongliang Liu, Doctor

Role: CONTACT

qiongliang.liu@shgh.cn

+8618117496385

Other Identifiers

20250228033833606

Identifier Type: -

Identifier Source: org_study_id